fate-nk100 as monotherapy and in combination with monoclonal antibody in subjects with advanced solid tumors

Conditions: HER2 Positive Gastric Cancer; Colorectal Cancer; Head and Neck Squamous Cell Carcinoma; EGFR Positive Solid Tumor; Advanced Solid Tumors; HER2-positive Breast Cancer; Hepatocellular Carcinoma; Non Small Cell Lung Cancer; Renal Cell Carcinoma; Pancreatic Cancer; Melanoma

Summary: this is a phase 1, single-dose, open-label, dose-escalation study. the study will be conducted in three parts (i.e. regimens) in an outpatient setting as follows: * regimen a: fate-nk100 as a monotherapy in subjects with advanced solid tumor malignancies. * regimen b: fate-nk100 in combination with trastuzumab in subjects with human epidermal growth factor receptor 2 positive (her2+) advanced breast cancer, her2+ advanced gastric cancer or other advanced her2+ solid tumors. * regimen c: fate-nk100 in combination with cetuximab in subjects with advanced colorectal cancer (crc) or head and neck squamous cell cancer (hnscc), or other epidermal growth factor receptor 1 positive (egfr1+) advanced solid tumors.


Eligibility criteria:
inclusion criteria: 1. regimen a only (monotherapy): subjects with advanced metastatic solid tumors 2. regimen b only (combination with trastuzumab): subjects with advanced metastatic her2+ solid tumors 3. regimen c only (combination with cetuximab): subjects with advanced metastatic egfr+ solid tumors 4. available related donor who is cmv+ and hla-haploidentical or better but not fully hla-matched 5. presence of measurable disease by recist 1.1 6. life expectancy of at least 3 months. 7. provision of signed and dated informed consent form (icf). 8. stated willingness to comply with study procedures and duration. exclusion criteria: 1. females of reproductive potential that are pregnant or lactating, and males or females not willing to use a highly effective form of contraception from screening through the end of the study. 2. eastern cooperative oncology group (ecog) performance status \>2. 3. evidence of insufficient organ function as determined by the protocol. 4. receipt of any biological therapy, chemotherapy, or radiation within 1 week of the screening visit and at least 3 weeks prior to day 1, except for patients receiving maintenance trastuzumab. 5. have central nervous system disease (cns) as follows: 1. dose escalation cohorts: active cns disease, including history of cns metastases. 2. mtd/mfd expansion cohorts: cns disease, including history of cns metastases, that was not stable during the last 6 months. 6. myocardial infarction (mi) within 6 months of screening visit. 7. severe asthma. 8. currently receiving or likely to require systemic immunosuppressive therapy from day -7 to day 29. 9. uncontrolled infections. 10. presence of any medical or social issues that are likely to interfere with study conduct, or may cause increased risk to subject.

Keywords: solid tumor her2 egfr advanced solid tumor breast cancer head and neck cancer head and neck squamous cell carcinoma colorectal cancer gastric cancer her2 positive egfr positive egfr+ her2+ immunotherapy nk cell therapy natural killer cell therapy antibody-dependent cell-mediated cytotoxicity adcc non small cell lung cancer renal cancer